Adrenaline S.A.L.F.

Package leaflet: Information for the user

ADRENALINA S.A.L.F. 0.5 mg/ml injection solution, 1 mg/ml injection solution

Adrenaline
Equivalent medicine
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ADRENALINA S.A.L.F. is and what it is used for
2. What you need to know before using ADRENALINA S.A.L.F.
3. How to use ADRENALINA S.A.L.F.
4. Possible side effects
5. How to store ADRENALINA S.A.L.F.
6. Contents of the pack and other information

1. What ADRENALINA S.A.L.F. is and what it is used for

ADRENALINA S.A.L.F. contains the active substance adrenaline, which belongs to a group of medicines called adrenergic and dopaminergic agents.
ADRENALINA S.A.L.F. can be used in emergency situations to treat anaphylactic shock, a sudden and potentially life-threatening allergic reaction, and angioedema, characterized by swelling of the face, lips, tongue, and breathing difficulties caused by insect stings or bites, foods, medicines, or other substances.

2. What you need to know before using ADRENALINA S.A.L.F.

Do not use ADRENALINA S.A.L.F.

• if you are allergic to adrenaline or to any of the other ingredients of this medicine (listed in section 6);
• if you have collapse due to severe circulatory problems (shock);
• if you suffer from heart diseases (organic cardiac conditions), such as an enlarged heart (cardiac hypertrophy) or irregular heartbeat (arrhythmias);
• if you have organic brain damage;
• if you suffer from impaired blood circulation to the brain (cerebral arteriosclerosis);
• if you have a type of eye disease caused by high intraocular pressure (angle-closure glaucoma).

Adrenaline must not be administered during general anesthesia with chloroform, trichloroethylene, or
cyclopropane, and must be used with caution with other halogenated anesthetics (e.g. halothane).
Adrenaline must not be injected into certain areas, such as fingers or tongue, during local anesthesia, as it may
cause tissue damage and tissue death (necrosis) due to reduced blood supply to these areas.
Adrenaline must not be used during the second stage of labor (see section “Pregnancy and
breast-feeding”).

Warnings and precautions
Talk to your doctor or pharmacist before you are given ADRENALINA S.A.L.F.
This medicine must be administered with particular care in the following cases:

• if you are elderly;
• if you have diabetes;
• if you suffer from heart or circulatory problems;
• if you are allergic to certain substances similar to adrenaline called sympathomimetic amines.

Injections into the gluteal region must be avoided, as they may cause tissue damage and necrosis.
Prolonged use of this medicine may cause an alteration in blood pH (metabolic acidosis).
For athletes, the use of this medicine without genuine therapeutic need constitutes doping
and may lead to a positive result in anti-doping tests.

Other medicines and ADRENALINA S.A.L.F.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Adrenaline must not be administered together with the following medicines:

• other substances similar to adrenaline (sympathomimetic agents), as they may increase the activity and toxicity of adrenaline;
• alpha- and beta-blocking agents used to lower blood pressure, such as propranolol, phentolamine, and medicines used for migraine (dihydroergotoxine), as they may reduce the effect of adrenaline;
• medicines used during anesthesia such as cyclopropane and halothane (halogenated anesthetics) (see section “Do not use ADRENALINA S.A.L.F.”) and medicines used to treat irregular heartbeat (cardiac glycosides), especially at high doses, as they may cause disturbances in heart rhythm (arrhythmias, tachycardia, fibrillation);
• medicines for depression such as tricyclic antidepressants (e.g. imipramine), certain antihistamines used for allergies (e.g. diphenhydramine, tripelennamine, and deschlorpheniramine), and thyroid hormones, as they may enhance the effects of adrenaline;
• insulin and other medicines used to lower blood sugar levels, as higher doses of these medicines may be required;
• clonidine, a medicine used for high blood pressure, doxapram, a medicine used for respiratory difficulties, and oxytocin, used during childbirth, as they may cause an increase in blood pressure (hypertension);
• dopexamine, a medicine used to improve heart function, and entacapone, a medicine used for Parkinson’s disease, as they may increase the action of adrenaline;
• medicines used for mental disorders (antipsychotics), as they may reduce the effects of the medicine;
• medicines used to treat headaches (ergotamine and methysergide), as their use together with adrenaline may increase the risk of poisoning due to the active ingredient in these medicines (ergotism).

Adrenaline must not be used to treat circulatory collapse or low blood pressure
caused by phenothiazines (antipsychotic medicines), as it may cause a further drop in blood pressure.

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breast-feeding,
ask your doctor or pharmacist for advice before this medicine is administered.
Adrenaline must not be administered during childbirth, as it inhibits uterine contractions and may
delay the second stage of labor.
This medicine must not be administered during pregnancy unless absolutely necessary and under
direct medical supervision, as it may cause problems for the fetus.
Avoid breast-feeding if you are given this medicine, as adrenaline passes into breast milk.

Driving and using machines
There are no data available to determine the effect of this medicine on the ability to drive and use
machinery.

ADRENALINA S.A.L.F. contains sodium and sodium metabisulfite
This medicine contains less than 1 mmol (less than 23 mg) of sodium per dose, i.e. it is practically 'sodium-free'.
This medicine contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use ADRENALINA S.A.L.F.

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
ADRENALINA S.A.L.F. must not be injected into the buttock.
The recommended dose is 0.5 – 1 mg administered by intramuscular injection, repeated every 10 minutes until improvement is achieved. During treatment, blood pressure and heart rate must be closely monitored.
In more severe cases, slow intravenous infusion of 0.5 mg may be required, at an infusion rate of 100 micrograms per minute, after appropriate dilution to 1:10,000 (e.g., 1:10 ml dilution in the case of a syringe).

Use in prepubertal adolescents or those with reduced growth
Use in children (under 12 years of age)

• Up to 6 months: the recommended dose is 50 micrograms administered intramuscularly.
• From 6 months to 6 years: the recommended dose is 120 micrograms intramuscularly for robust children and 60 micrograms for underweight children.
• From 6 to 12 years: the recommended dose is 250 micrograms administered intramuscularly.

In more severe cases, slow intravenous infusion (endovenous infusion) may be required at a dose of 10 micrograms per kg of body weight, after appropriate dilution to 1:10,000 (e.g., 1:10 ml dilution in the case of a syringe).

If you use more ADRENALINA S.A.L.F. than you should
In case of overdose or accidental injection of adrenaline, inform your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include: a marked increase in blood pressure, which may lead to bleeding in the blood vessels of the brain (cerebrovascular haemorrhage) or in other areas, motor impairment (hemiplegia), particularly in the elderly, disturbances in heart rhythm (bradycardia, tachycardia, potentially fatal arrhythmias), kidney function problems, alteration of blood pH (metabolic acidosis), and accumulation of fluid in the lungs (pulmonary edema).
Treatment includes administration of medicines that counteract the effects of adrenaline. An alpha-blocker such as phentolamine should be given, followed by a beta-blocker such as propranolol. In cases of severe hypertension, other medicines such as sodium nitroprusside or nitrites may also be administered to restore blood pressure to normal levels.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data)

• heart problems, such as changes in heart rate (potentially fatal cardiac arrhythmias, palpitations, tachycardia);
• stiffness, tremor, agitation, weakness, worsening or onset of psychomotor agitation;
• headache, dizziness, lightheadedness, excitability;
• nervousness, insomnia, disorientation, confusion, panic, hallucinations;
• psychiatric problems and tendencies to harm oneself or others (suicidal or homicidal tendencies);
• nausea, vomiting;
• excessive sweating and pallor;
• difficulty breathing or cessation of breathing (apnea). Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ADRENALINA S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Store below 25°C. Do not freeze.
The solution should be clear, colourless or slightly yellow, and free from visible particles. The ampoule is intended for single and uninterrupted administration; any remaining solution must not be used.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What ADRENALINA S.A.L.F. contains
ADRENALINA S.A.L.F. 0.5 mg/ml solution for injection

• The active substance is adrenaline. Each vial contains 0.5 mg of adrenaline.
• The other components are: sodium chloride, sodium metabisulfite, hydrochloric acid, water for injections.

ADRENALINA S.A.L.F. 1 mg/ml solution for injection

• The active substance is adrenaline. Each vial contains 1 mg of adrenaline.
• The other components are: sodium chloride, sodium metabisulfite, hydrochloric acid, water for injections.

Description of the appearance of ADRENALINA S.A.L.F. and contents of the pack
Pack containing 5 vials of 1 ml solution for injection.
Marketing Authorisation Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico
Via Marconi, 2
24069 Cenate Sotto (BG)
Italy